SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2

Syringe, Piston

HARVEST TECHNOLOGIES, CORP.

The following data is part of a premarket notification filed by Harvest Technologies, Corp. with the FDA for Smartjet Grafting Liquid Applicator, Models Sk/s & Lk/2.

Pre-market Notification Details

Device IDK020252
510k NumberK020252
Device Name:SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2
ClassificationSyringe, Piston
Applicant HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD, SUITE 100 Plymouth,  MA  02360
ContactJohn D Bonasera
CorrespondentJohn D Bonasera
HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD, SUITE 100 Plymouth,  MA  02360
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-24
Decision Date2002-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35020583514547 K020252 000
35020583514530 K020252 000
35020583514523 K020252 000
35020583514516 K020252 000
05020583514539 K020252 000
05020583514522 K020252 000
05020583514546 K020252 000
05020583514515 K020252 000

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